Career CategoryClinical
Job DescriptionBiostatistical Programming Senior Manager
What you will doLet's do this. Let's change the world. In this vital role you will be responsible for programming activities supporting the obesity therapeutic area. This individual will report to the Director of General Medicine - Obesity programming in CfOR's Data & Analytic Center.
The senior manager provides leadership to the obesity programming team in the development and execution of real-world evidence (RWE) observational studies and ensures adequate and timely delivery of results. The individual is responsible for oversight of the US programming team and planning, organizing, and managing resources to ensure high quality and timely delivery of observational research programming deliverables. The senior manager leads and contributes to efforts to identify, develop and implement departmental standards, applications, processes, and training. This position requires management of a technical team and a comprehensive understanding of statistical programming languages and platforms, real world data, claims, and EMR databases.
Key activities include:
- Lead, manage, and develop programming staff
- Provide technical solutions to programming problems within CfOR
- Lead and develop technical programming and process improvement initiatives within CfOR
- Represent the programming function and participate in multidisciplinary project team meetings
- Project manage all programming activities, according to agreed resource and timeline plans
- Ensure all programming activities on the project adhere to departmental standards
- Write and/or review and approve all programming plans
- Write and/or review and approve analysis dataset specifications
- Review and approve key study-related documents produced by other functions, e.g. SAPs, CRF, Data Management Plan, etc.
- Write, test and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications
- Write, test, validate and execute department-, product- and protocol-level macros and utilities
- Oversee the work of outsourced resources assigned to project
- Review Requests for Proposals (RFPs) from outsourcing vendors for programming services
- Lead and/or participate in the development and review of CfOR Policies, SOPs and other controlled documents
- Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings
- Participate in the recruitment of programming staff
- Actively participate in external professional organizations, conferences and/or meetings
- Provide input to and participate in intra-departmental and CfOR meetings
- Contribute to the continuous improvement of programming, CfOR, and Research and Development (R&D)
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The Biostatistical Programming Senior Managerwe seek is a proffesional with these qualifications.
- Doctorate degree and 2 years of experience
OR
Master's degree and 4 years of experience
OR
Bachelor's degree and 6 years of experience
OR
Associate's degree and 10 years of experience
OR
High school diploma / GED and 12 years of experience
Preferred Qualifications- Bachelor's or Master's degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject
- For therapeutic area support, ten (10) years clinical research and development programming and managing experience
- For system and process support, ten (10) years project management, software application development and managing experience
- Drug Development (pre-, early, late and/or observational) in related industries or academic research)
- Project planning and management
- Process improvement leadership
- Participation in the development of policies and SOPs
- International co-operation
- Computer programming, preferably SAS or other procedural languages
- Understanding of computer operating systems, UNIX preferred
- Biostatistical Programming within Drug Development
- Drug Development Process & Operations
- Software development & design
What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadlineAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
SponsorshipSponsorship for this role is not guaranteed.
Salary Range151,838.05USD -205,427.95 USD
